Nanostim™ Leadless Pacemaker

This device is commercially available for use in select international markets.

No Lead. No Pocket. No Compromise.

We are proud to introduce the Nanostim™ leadless pacemaker, the world’s first, commercially available leadless pacemaker and one that is designed to be repositioned or retrieved if needed. For the past 40 years the therapeutic promise of leadless pacing has been discussed, but until now, no one has been able to overcome the technical challenges. Today, St. Jude Medical, the company that delivered the world’s first cardiac pacemaker in 1958, is once again demonstrating how we transform challenges into revolutionary healthcare solutions.

How will leadless pacing revolutionize your practice?

No lead is required for the Nanostim™ leadless pacemaker, which is small enough to fit entirely inside the right ventricle and is designed for retrievability. When you no longer have to implant leads, you eliminate the known risks of lead failure, lead removal, and the hemodynamic impact of the lead crossing the tricuspid valve.

Plus, with the elimination of the surgical pocket that traditionally holds the pacemaker and lead, the result is no visible device and subsequent scar. In addition, your patient’s risk for decreased mobility restrictions due to the lead and pocket discomfort is eliminated. The Nanostim™ leadless pacemaker comes with a 10 year warranty and may last longer depending on your pacing needs.

When you implant a device that eliminates leads and the surgical pocket, you can deliver therapy without compromise.

How does leadless pacing longevity compare to standard solutions?

With the Nanostim™ leadless pacemaker, you do not need to compromise on longevity. The Nanostim™ leadless pacemaker comes with the same St. Jude Medical 10-year warranty as our traditional single-chamber devices.

How does leadless pacing work?

We designed the Nanostim™ leadless pacemaker for easy deployment and retrieval. The Nanostim leadless pacemaker is delivered using an 18 F introducer via the femoral vein and is placed into the right ventricle. This VVIR pacemaker attaches with a double fixation mechanism and paces the heart using a St. Jude Medical steroid-eluting electrode. If the implanter is not satisfied with pacing parameters, the device can be repositioned with the delivery catheter.

The Nanostim™ leadless pacemaker is designed for retrievability if the need arises. This is facilitated by a docking port that mates to our retrieval catheter, allowing the operator to apply enough torque to safely remove the device.

Programming

We understand how important simplified programming and follow-up care are to your practice. We designed the world’s first CE-marked leadless pacemaker to be compatible with the St. Jude Medical Merlin™ Patient Care System (PCS). To further support your workflow, our Nanostim™ Link software also uses the same user interface as St. Jude Medical programming software.

MATERIALS & LINKS

Nanostim™ Leadless Pacing for Patients

Retrievability

Designed for retrievability

Seamless, Polished Titanium

This seamless, polished titanium housing is non-porous and completely washed in the cardiac cycle. Chronic animal studies have demonstrated that the device does not encapsulate like a traditional lead.1

Easy to Capture, Torque and Remove

The docking button offers simplified capture and the retrieval tools feature a metal-to-metal interface that allows the user to apply a high torque factor compared to traditional lead extraction.

Economic & Clinical Facts

More than four million people around the world have an implanted pacemaker or other cardiac rhythm management device, and 700,000 additional patients receive an implant every year. Although the incidence of pacemaker complications is relatively low, the magnitude of the device patient population means that these events can have a major economic impact on the clinic and healthcare system. They also have a serious impact on the patient’s quality of life.

Bacterial infection is responsible for the majority of implantable pulse generator (IPG) complications, and the increase in admissions for pacemaker infections is growing at twice the rate than the pacemaker implantation growth rate1, 2

The chances of developing an implantable pulse generator (IPG) infection increases based on the type of procedure being performed, and the patients’ medications and characteristics.

The Burden of IPG Infections

The in-hospital mortality rate for a pacemaker infection is 8.4%, and the 15 month post-implant mortality rate for pacemaker patients with an infection is 36.3%, more than double the 15.4% mortality rate of uninfected pacemaker patients.14

Average hospital length of stay (LOS) for a pacemaker patient with an infection is 14.4 days, compared to 4.8 days for patients without an infection.15

In the U.S., the incremental cost of treating a pacemaker patient with an infection ranges from $16,852 to $24,459.16

In Germany, the cost of treating an infected pacemaker patient is €7,09117

Effective October 1, 2012, Medicare and Medicaid do not reimburse hospitals for IPG infections acquired during a hospital stay18

Clinical Facts

Trandtional Pacemaker Complications

Frequency

Lead dislodgement

2.2% to 3.7%3

Pneumothorax (80% require chest tube)

1.6% to 2.6%4,5,6,7

Severe venous thrombosis

1% to 3%4,5,6,7

Chronic lead failure

2% to 4%4,5,6,7

Single chamber infection rate (de novo)

1%6,7,8

Pacemaker infection rate (replacement)

1% to 2%9

Skin erosion

0.8%10

Device migration

2% to 4%11,12

Pocket hematoma (prolonged hospitalization/reoperation)

2% / 1%13

Note: Catheter ablation procedures, which utilize a femoral vein approach, may result in vascular complications such as femoral pseudoaneurysms or groin hematomas at rates between 0.93%9-2.4%.10 These ablation catheters used in EP procedures typically use smaller-sized introducers for access (≤8.5F).

Indications
The Nanostim™ leadless pacemaker is indicated for:
Chronic atrial fibrillation with 2 or 3° AV or bifascicular bundle branch block (BBB),
Normal sinus rhythm with 2 or 3° AV or BBB block and a low level of physical activity or short expected lifespan, or
Sinus bradycardia with infrequent pauses or unexplained syncope with EP findings.

Contraindications
Use of any pacemaker in patients with a co-implanted ICD is contraindicated because high-voltage shocks could damage the pacemaker, and the pacemaker could reduce shock effectiveness.
Single-chamber ventricular demand pacing is relatively contraindicated in patients who have demonstrated pacemaker syndrome, have retrograde VA conduction, or suffer a drop in arterial blood pressure with the onset of ventricular pacing.
Programming of rate-responsive pacing is contraindicated in patients with intolerance of high sensor-driven rates.
The leadless pacemaker is contraindicated for use in patients with pre-existing pulmonary arterial (PA) hypertension (PA systolic pressure > 40 mmHg or RV systolic pressure > 40 mmHg) or significant physiologically-impairing lung disease.
Use in patients with an implanted vena cava filter or mechanical tricuspid valve is contraindicated because of interference between these devices and the delivery system during implantation.
Use is contraindicated in patients who are expected to be hypersensitive to a single dose of 0.7 milligrams of dexamethasone sodium phosphate.

Warning:
Do not implant an additional Nanostim™ leadless pacemaker in the presence of an implanted Nanostim™ leadless pacemaker, because this has not been tested. Do not implant the device in the presence of an implanted transvenous lead, because this has not been
tested.
Do not put excessive forward pressure on the protective sleeve or the delivery catheter when implanting the device, because perforation may result. Do not turn the device more than 1.25 turns during implantation, because perforation may result. Careful consideration should be given to patients who have had cardiovascular or peripheral vascular surgery/intervention within the last 30 days because these patients may have a higher risk of complications.
Implant of a Nanostim™ leadless pacemaker should not be attempted in the presence of an active perforation. Implant sites where a previous clinical event such as perforation or lead extraction with myocardial tissue removal should be avoided as this may result in a higher rate of perforation.

Devices depicted may not be available in all countries. Check with your St. Jude Medical representative for product availability in your country.

Rx Only. Please review the Instructions for Use prior to using these devices for a complete listing of indications, contraindications, warnings, precautions, potential adverse events and directions for use.

Product referenced is approved for CE Mark.

NanostimTM leadless pacemaker is designed, developed and manufactured by St. Jude Medical.